MIRANDOLA, Italy and MONMOUTH JUNCTION, N.J., Sept. 11, 2017 /PRNewswire/ -- Aferetica srl, an innovative start-up specializing in blood purification, and CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing CytoSorb® to treat deadly inflammation, announced a new collaboration to jointly develop the PerLife™ ex-vivo organ perfusion system with CytoSorbents' novel adsorption technologies that can cleanse and recondition harvested solid organs such as the kidney, lungs, heart, and liver prior to transplantation. The goal of the therapy is to improve the functioning and viability of the organs, while reducing the risk of primary graft failure and organ rejection. This may help to recondition marginal organs that are typically discarded, expand the availability of scarce, suitable organs, and ensure the success of costly transplantation procedures.
Under the terms of the agreement, Aferetica will lead the development and regulatory approval of the PerLife System, while CytoSorbents will provide dedicated, branded sorbent cartridges for use with the platform. CytoSorbents and Aferetica will finalize the commercial arrangements for distributing the PerLife System, including sorbent cartridges, prior to the anticipated market introduction starting in Italy later this year and followed by select European Union countries in 2018.
Mr. Mauro Atti, Chief Executive Officer of Aferetica stated, "We are delighted to expand our relationship with CytoSorbents, where we have successfully introduced CytoSorb to Italian hospitals where it has demonstrated its great potential to save lives. Together, we will now target the rapidly growing field of organ transplantation. Aferetica has been advancing the PerLife System to maximize the viability of transplanted organs, improve transplant outcomes, and give more potential to human life. The PerLife System, when combined with CytoSorbents' novel purification technology, has the potential to play an important role before, during, and after transplant surgery, as already confirmed by recent and important studies in collaboration with some of the most important Italian universities."
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "Currently, there is a severe worldwide shortage of donor organs. According to the Global Observatory on Donation & Transplantation, there were approximately 120,000 solid organs transplanted in 2014, which was less than 10% of the global need. Transplanted kidneys account for approximately two-thirds of all transplants, yet based on research performed by UNOS, the United Network for Organ Sharing, nearly 20 percent of all deceased donor kidneys are discarded, mainly because they do not meet kidney donor quality criteria. For example, cytokine storm and severe inflammation in organ donors who die of traumatic injury can damage and reduce the functioning of these organs, resulting in a higher risk of graft failure after transplant, and even decreased long-term survival. By reconditioning organs prior to transplant, the PerLife System, utilizing CytoSorbents' sorbent technology, has the potential to positively impact the field, by improving the quality and supply of harvested organs, while reclaiming many marginal organs that would otherwise be discarded."
Mr. Chris Cramer, Vice President of Business Development of CytoSorbents commented, "The expansion of this partnership is very exciting because it provides the opportunity to bring CytoSorbents' sorbent technology to a new set of customers in a new clinical application where there is a major unmet medical need. We believe the use of the PerLife system to optimize organ function before the surgery, and CytoSorb after the surgery, if needed, will enable transplant surgeons to experience the benefits of CytoSorbents' technologies. Aferetica has been an outstanding partner and has already demonstrated the ability to rapidly grow the CytoSorb business in Italy. We are pleased to launch this collaboration for organ transplantation with Aferetica and look forward to continued success with them in this new field."
About Aferetica srl (Mirandola, Modena)
Founded by Mauro Atti and Stefano Rimondi, leaders with decades of experience in dialysis, intensive care, cardiology and medical devices in general, Aferetica is innovative start-up specializing in blood purification to provide the Health care system with systems for therapeutic apheresis to support special procedures like Organ Transplant and to treat critical illnesses such as sepsis, autoimmune diseases, and other illnesses caused by undesirable mediators.
Aferetica is based in the incubator of the Biomedical District of Mirandola, Italy, district that brings with it as a common heritage of knowledge, technologies, and production capacities allowing to quickly and efficiently develop therapies and products. Most of the innovations born in Europe in the field of blood purification spring from ideas and activities carried out in collaboration between industry, clinicians, and academicians around this territory. The Aferetica partners have always believed this is the main road leading to real and concrete innovation and have with their activities contributed to the growth of collaborative research, the building block of the company.
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 44 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis, as well as in cancer immunotherapy. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. CytoSorbents has completed its REFRESH (REduction in FREe Hemoglobin) 1 trial – a multi-center, randomized controlled study that has demonstrated the safety and efficacy of free hemoglobin reduction with intra-operative CytoSorb® use in a heart-lung machine during complex cardiac surgery. In 2017, the company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval. CytoSorb® has been used safely in more than 27,000 human treatments to date.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $20 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM) and others. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents and multiple applications pending, including CytoSorb-XL, HemoDefend™, VetResQ™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter
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